1. Durban, South Africa January 29 to 31, 2013 Topic 6: Flexibilities Related to the Definition of Patentable Subject Matter Regional Seminar for Certain African Countries on the Implementation and Use of Several Patent-Related Flexibilities REPUBLIC OF SOUTH AFRICA

2. Flexibilities Related to the Definition of Patentable Inventions – the TRIPS Agreement Thu-Lang TRAN WASESCHA Counsellor, Intellectual Property Division WTO Secretariat Tran Wasescha- January 2013 WIPO-DTI Regional Seminar for Certain African Countries on the Implementation and Use of Several Patent-Related Flexibilities Durban, South Africa, 29-31 January 2013

3. Outline The WTO The TRIPS (Trade-Related Aspects of Intellectual Property Rights) Balance of interests – Negotiations, «acquis» – Implementation – Future and challenges

4. The WTO in a nutshell 158 Members, last being Laos. More than 96 of trade in goods and services (together) Multidisciplinary complex mechanism of negotiations, trade-offs across the board Member-driven methodology, consensus rule. Single undertaking – nothing is agreed until everything is agreed – Pluri-lateral avenue, e.g. Government Procurement Agreement Dispute settlement system and sanctions

5. TRIPS – balance of interests Paris, Berne Conventions. Balance of interests already carefully negotiated. Incorporation of WIPOs basic conventions TRIPS: Plus certain elements or re-affirmations or clarifications Balance of interests negotiation of flexibilities, e.g. exhaustion of rights, patentability Flexibilities and constructive ambiguity

6. 6 The IP planet Paris IPIC Rome Paris Berne IPIC Rome FTAs (bilateral or regional) TRIPS WIPO treaties, etc. National laws Regional legislation EU, OAPI, ARIPO, EPC, etc.

7. 7 Minimum level of protection! n Subject to transitional arrangements for certain Members n Freedom to go beyond this level: national laws (CH, US, Japan, Korea, etc. ), regional laws (EU), bilateral and regional agreements, e.g. Free Trade Agreements, WIPO treaties n "Shall" provisions and "may" provisions + obligations tempered (shall have the authority) n WTO Dispute Settlement System TRIPS: general

8. TRIPS – Invention NO definition See, however, national / regional legislation – OAPI: accord de Bangui, annexe I, article 1 er – ARIPO: part III, article 7 – etc.

9. Techniques of defining: patentable inventions Patentable inventions ; TRIPS «patentability» and exclusions from patentability Non-discrimination between fields of technology (in principle: see following slides or other sessions, e.g. on compulsory licenses): Art.27.1 Product and process inventions: mandatory (Art. 27.1)

10. Techniques of defining: patentable inventions Requirements for an invention to be patentable (Art. 27.1): – Novelty, inventive activity and industrial application + [Disclosure under Article 29] Exclusions from patentability: – An invention fulfills the three conditions but it can be not patented (n.b.: simplified summary of Art. 27.2): Ordre public Morality Damage to human, animal and health, environment

11. Techniques of defining: patentable inventions Requirements for an invention to be patentable (Art. 27.1): – Novelty, inventive activity and industrial application + [Disclosure under Article 29] Exclusions from patentability: – An invention fulfills the three conditions but it can be not patented (n.b.: simplified summary of Art. 27.2): Ordre public Morality Damage to human, animal and health, environment

12. Techniques of defining: patentable inventions Requirements for an invention to be patentable (Art. 27.1): – Novelty, inventive activity and industrial application + [Disclosure under Article 29] Exclusions from patentability: – An invention fulfills the three conditions but it can be not patented (n.b.: simplified summary of Art. 27.2): Ordre public Morality Damage to human, animal and health, environment

13. Techniques of defining: patentable inventions A Member may exclude – a whole category of inventions for certain considerations; methods (diagnostic, therapeutic, and surgical) for human and animals (art. 27.3(a)) A Member may exclude: – Plants and animals (Art.27.3(b) – Essentially biological processes for production of micro- organisms (Art. 27.3(b)) Members shall not exclude from patentability – Micro-organisms – Non-biological and microbiological processes (Art.27.3(b))

14. Techniques of defining: patentable inventions Members shall protect plant varieties – By patents or – By an effective sui generis system or – By any combination thereof (Art.27.3(b)) Article 27.3.(b) shall be reviewed in 1999: different interpretations of review – Review of implementation – Review with a view to revision Traditional knowledge and farmers rights not addressed in TRIPS flexibility

15. Patentable inventions and related issues and work WTOs Work on issues of biotechnology/TRIPS- CBD/traditional knowledge (triplets), e.g in. TRIPS Council, regular session Declaration of Doha (WT/MIN(01)/DEC/1) and Declaration of Hong Kong (WT/MIN(05)/DEC) Director-Generals consultations. Focused on issues of disclosure in patent applications regarding genetic resources and related traditional knowledge. Grant of erroneous patents (e.g. lacking novelty or inventive activity): neem tree, turmeric The hoodia gordonia case

16. What relation between this and a dog ? VELCRO Burrs of the thistle (distel) Discovery and invention

18. Remarks Flexibilities in defining patentable inventions Common sense use of IP, of rights and obligations, of flexibilities (e.g. patentable inventions), otherwise Pendulum effects, which is not in the benefit of any party Sound and reasonable use of IP Foreign direct investment (even if it is one pre-requisite only among others). Africa: continent of hopes and possibilities (natural resources inventive activities patentable inventions)

19. 19 Consult our website www.wto.org Other questions to: n thu-lang.tranwasescha@wto.org; tel.: +41 22 739 57 05; # 3024 thu-lang.tranwasescha@wto.org